Early Clinical Results Unveiled at Society of NeuroInterventional Surgery

Annual Meeting

LAKE TAHOE, Calif., July 29 /PRNewswire/ -- Early clinical results from
the US and Argentina reveal that a new minimally invasive procedure
successfully eliminates pain and disability caused by lumbar spinal
stenosis (LSS), a condition that, in severe form, can cripple sufferers.
Announced today at the Society of NeuroInterventional Surgery (SNIS) Annual
Meeting in Lake Tahoe, Calif., these early results hold great promise for
the nearly 1.5 million patients who are newly diagnosed each year and the
neurointerventional practitioners committed to innovating new treatment
options as alternatives to traditional surgery.

According to Joshua A. Hirsch, M.D., study presenter and Director of
Interventional Neuroradiology/Endovascular Neurosurgery and Chief of
Minimally Invasive Spine Surgery at Massachusetts General Hospital, the
Minimally Invasive Lumbar Decompression (MILD(TM)) procedure offers
patients that previously would have required open surgical treatment an
efficacious alternative that can yield the same result with potentially
fewer complications and a shorter recovery period. "The beauty of this
procedure is that we have the opportunity to restore quality of life to
hundreds of thousands of patients who are affected by LSS with an incision
far smaller than a dime."

Lumbar stenosis is a narrowing of the spinal canal in the lower back,
known as the lumbar area. This narrowing occurs when bone and/or ligament
growth restricts the canal, squeezing and irritating the nerves that branch
out from the spinal cord. This compression causes patients to experience
low back pain, leg fatigue and pain, and, in severe cases, a significant
reduced capacity for physical activity, including walking.

Designed to remove the bone and enlarged ligaments that compress the
nerve roots, practitioners perform MILD(TM) using a recently-approved FDA
device developed by Vertos Medical, Inc. of San Jose, Calif. This
proprietary technology enables practitioners to first remove the bone --
known as a Laminotomy -- and then sculpt or thin the ligament.

To date, representatives of Vertos say that 42 patients have undergone
the MILD(TM) procedure with no adverse events. Ten patients have been
followed under an IRB-approved protocol designed to assess improvement of
pain and disability with commonly used measurement instruments, as well as
review narcotic intake. At six weeks post-treatment, the mean pain score
decreased 90 percent and the mean disability score improved 84 percent,
compared to baseline. Additionally, all 10 patients discontinued narcotics
use for pain.

Performing the MILD(TM) procedure under radiological guidance,
neurointerventional practitioners work through a metal tube -- or working
cannula -- inserted through a small incision in the skin directly at the
sight of the problem area. Physicians then place the Vertos device inside
the cannula, applying it to the relevant bone and ligaments. Because this
minimally invasive procedure allows practitioners to remove targeted
portions of the bone, MILD(TM) has the advantage of protecting against the
destabilization of the spine during the procedure. As with other minimally
invasive treatments, patients also benefit from local anesthesia, as well
as same- or next-day discharge.

According to Hirsch, like all new treatment options, the MILD(TM)
procedure will continue to undergo further study to validate these initial
promising results. If the procedure continues to yield the overwhelming
success that it has thus far, Hirsch continues, MILD(TM), like other now-
established neurointerventional techniques, will become yet another driving
force in the advancement of neurointerventional practice. "Compared to
other disciplines, our field is still relatively young. But it is
revolutionary therapies like this one that are giving neurointerventional
practitioners the opportunity to change the entire landscape of patient
care."

About SNIS

SNIS members are neurointerventional practitioners with backgrounds in
neuroradiology, neurosurgery and neurology that come together in the shared
discipline of neurointerventional surgery. Our practitioners specialize in
minimally invasive and endovascular procedures to treat stroke, aneurysms,
carotid stenosis and spine fractures. Over the past two decades, our
physicians have made numerous contributions to the neurosciences including:
advancing stroke treatment through catheter based therapy; innovating
endovascular coiling for aneurysms; pioneering interventional procedures to
treat fractures in the spine; and initiating the first-ever stroke registry
to track procedural success in the treatment of acute stroke. More
information on SNIS and our members' treatment specialties may be found at
http://www.snisonline.org

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